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. 2020 Sep;81(3):435-442.
doi: 10.1016/j.jinf.2020.06.023. Epub 2020 Jun 15.

Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2

Jhong-Lin Wu  1 , Wen-Pin Tseng  1 , Chien-Hao Lin  1 , Tai-Fen Lee  2 , Ming-Yi Chung  2 , Chien-Hua Huang  1 , Shey-Ying Chen  3 , Po-Ren Hsueh  4 , Shyr-Chyr Chen  1
Affiliations

Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2

Jhong-Lin Wu et al. J Infect. 2020 Sep.

Abstract

Objectives: We aimed to evaluate the role of rapid serological tests in the management of coronavirus disease 2019 (COVID-19) patients.

Methods: This retrospective study enrolled 16 real-time reverse transcription polymerase chain reaction-confirmed symptomatic patients with COVID-19 and 58 COVID-19 negative patients at a medical center in Taiwan over a 3-month period. Serial serum samples were collected and tested for antibody response using four point-of-care (POC) lateral flow immunoassays (LFIA) (ALLTEST 2019-nCoV IgG/IgM Rapid Test, Dynamiker 2019-nCoV IgG/IgM Rapid Test, ASK COVID-19 IgG/IgM Rapid Test, and Wondfo SARS-CoV-2 Antibody Test). Time-dependent detection sensitivity and timeliness of seroconversion were determined and compared between the four POC rapid tests.

Results: The overall sensitivity and specificity of the four tests for detecting anti-SARS-CoV-2 antibodies after 3 weeks of symptom onset were 100% and 100%, respectively. There was no significant difference between the rapid tests used for detection of IgM and IgG separately and those used for detection of combined total antibody (mainly IgM/IgG). There was no significant difference between the four POC rapid tests in terms of time required for determining seroconversion of COVID-19. Patients with COVID-19 with pneumonia demonstrated shorter seroconversion time than those without pneumonia.

Conclusion: Though the POC antibody rapid tests based on LFIA showed reliable performance in the detection of SARS-CoV-2-specific antibodies, the results of these tests should be interpreted and applied appropriately in the context of antibody dynamic of COVID-19 infection. COVID-19 patients complicated with pneumonia exhibited earlier anti-SARS-CoV-2 antibody response than COVID-19 patients without pneumonia.

Keywords: Antibody response; COVID-19 pandemic; Immunochromatographic assay; Lateral flow method; Rapid test.

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Conflict of interest statement

Declaration of Competing Interest The authors declare no conflict of interest.

Figures

Fig 1
Fig. 1
Percentage of samples with positive antibody response determined using the four studied point-of-care antibody rapid tests after symptom onset. A. ALLTEST ASK COVID-19 IgG/IgM Rapid Test. D. Wondfo SARS-CoV-2 Antibody Test.
Fig 2
Fig. 2
Parallel comparisons of cumulative probability of detection of seroconversion detection between the four studied point-of-care antibody rapid tests.
Fig 3
Fig. 3
Detection of seroconversion in patients with COVID-19 with or without pneumonia using the four point-of-care antibody rapid tests. A. ALLTEST 2019-nCoV IgG/IgM Rapid Test. B. Dynamiker 2019-nCoV IgG/IgM Rapid Test. C. ASK COVID-19 IgG/IgM Rapid Test. D. Wondfo SARS-CoV-2 Antibody Test.
See this image and copyright information in PMC

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